Package Insert: Information for the User

Alprazolam Tarbis 0.25 mg Tablets EFG

Read this package insert carefully before starting to take the medication, as it contains important information for you.

• Keep this package insert, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed only for you, and you should not give it to others, even if they have the same symptoms of illness as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this package insert.

Alprazolam belongs to a group of medicines called benzodiazepines (anxiolytic medicines).

This medicine is used in adults for the treatment of severe, debilitating, or extremely distressing anxiety symptoms. This medicine is only for short-term use.

Do not take Alprazolam

• If you are allergic to alprazolam, benzodiazepines, or any of the other components of this medication (listed in section 6)
• If you have respiratory difficulties related or unrelated to sleep (sleep apnea)
• If you have a condition called myasthenia gravis characterized by muscle weakness
• If you have severe liver damage

Warnings and precautions

To minimize the risk of dependence, the following precautions should be taken:

Alprazolam with other medications

Inform your doctor or pharmacist if you are using, have used recently, or may need to use another medication,

Alprazolam may interact with other medications. Inform your doctor or pharmacist if you are taking any of the following medications:

• Central nervous system depressants, as they may potentiate the sedative effect of Alprazolam Tarbis:

• Major tranquilizers (antipsychotics).
• Sleep inducers (hypnotics).
• Medications used to treat depression.
• Medications for epilepsy treatment (antiepileptics).
• Opioid analgesics and narcotics (morphine derivatives), as they may increase the feeling of euphoria, leading to increased psychological dependence.
• Medications used to treat anxiety (anxiolytics/sedatives).
• Anesthetics.
• Sedating antihistamines (allergy medications).
• The concomitant use of Alprazolam Tarbis and opioids (potent analgesics, addiction treatment medications, and some cough medications) increases the risk of drowsiness, respiratory depression, coma, and may be potentially fatal. Therefore, concomitant use should only be considered when other treatment options are not possible.
• However, if your doctor prescribes Alprazolam Tarbis with opioids, the dose and duration of concomitant treatment should be limited by your doctor.
• Inform your doctor about all opioid medications you are taking and follow your doctor's dosage recommendations closely. It may be helpful to inform friends or family members to be aware of the signs and symptoms mentioned above. Contact your doctor if you experience any of these symptoms.

• There are some groups of medications that, due to their action in the body (cytochrome P450 inhibitors), may interact with Alprazolam Tarbis and, in some cases, increase its activity. Some of the medications that may interact with Alprazolam Tarbis are:

• Medications used to treat fungal infections such as ketoconazole, itraconazole, posaconazole, or voriconazole. It is not recommended to take them at the same time as Alprazolam Tarbis.
• The following antidepressants: nefazodone, fluvoxamine, and fluoxetine.
• Gastric protectors such as cimetidine.
• Dextropropoxyphene (narcotic analgesic).
• Oral contraceptives.
• Diltiazem (anti-hypertensive).
• Macrolide antibiotics such as erythromycin, troleandomycin, clarithromycin, and telithromycin.
• Medications used to treat HIV/AIDS such as ritonavir, etc.

Digoxin (medication used to suppress or prevent heart rhythm alterations).

Alprazolam with food, drinks, and alcohol

During treatment, avoid alcoholic beverages. The effect of alcohol may potentiate sedation, and this may affect your alertness (see section "Driving and operating machinery").

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, or think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medication.

This medication is not recommended during pregnancy or breastfeeding, unless, in the doctor's opinion, the benefits outweigh the risks for the baby.

If, by the doctor's decision, this medication is administered during a late stage of pregnancy or during delivery, certain effects may occur in the newborn, such as decreased body temperature (hypothermia), decreased muscle tone (hypotonia), and moderate respiratory depression.

Children born to mothers who take benzodiazepines chronically during the last stage of pregnancy may develop physical dependence, and a withdrawal syndrome may occur in the postnatal period.

Use in children and adolescents (under 18 years)

Alprazolam is not recommended for children and adolescents under 18 years. Benzodiazepines should not be administered to children unless it is strictly necessary and prescribed by a doctor. The efficacy and safety of alprazolam have not been established in children under 18 years.

Use in elderly patients (over 65 years)

Alprazolam Tarbis may affect this group of patients more than young patients. If you belong to this group, your doctor may reduce the dose and check your response to treatment. Please follow your doctor's instructions carefully (see section "How to take Alprazolam Tarbis").

Benzodiazepines and related products should be used with caution in elderly patients, due to the risk of sedation and/or muscle weakness that may cause falls, often with serious consequences in this population.

Special patient groups

If your liver or kidneys do not function well, consult your doctor, who may advise you to use a lower dose of Alprazolam Tarbis.

If you have respiratory problems, inform your doctor.

Driving and operating machinery

Alprazolam may affect your ability to drive or operate machinery, as it may cause drowsiness, decrease your attention, or decrease your reaction time. The appearance of these effects is more likely at the beginning of treatment or when the dose is increased. Do not drive or operate machinery if you experience any of these effects. These effects may be potentiated if you consume alcohol at the same time.

Alprazolam contains lactose

If your doctor has told you that you are intolerant to certain sugars, consult with them before taking this medication.

Alprazolam contains sodium benzoate

This medication contains0.12mg ofsodium benzoate (E-211)in each 0.25 mg tablet.

This medication contains less than 23 mg of sodium (1mmol) per tablet; it is essentially "sodium-free".

Follow exactly the administration instructions of this medication as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

Dosage:

The tablet or its part will be ingested without chewing, with the help of a little liquid. Your doctor will prescribe the most suitable alprazolam presentation, according to the dose you need.

Usual doses are as follows:

- The initial dose is 0.25mg to 0.5mg of alprazolam three times a day.

-The usual dose ranges from 0.5mg to a maximum of 4 mg per day, divided into 2 or 3 doses.

In elderly patients, with chronic respiratory insufficiency, liver or kidney impairment, the recommended initial dose is 0.25mgof alprazolam, 2 or 3 times a day, with a daily alprazolam intake of 0.5mg to 0.75mg in divided doses, which can be gradually increased as needed and well tolerated.

No individual dose should exceed the indicated limits, and the total daily dose should not either, unless your doctor indicates otherwise.

Duration and discontinuation of treatment:

The maximum durationof treatment should not bemore than 2-4 weeks. Long-term treatment is not recommended. If your doctor considers it necessary to prolong treatment in your case, they will do so for limited periods and will frequently monitor your situation.

Never discontinue treatment abruptly. Your doctor will indicate the duration of treatment depending on the evolution of your disease and will explain how to gradually reduce the dose until you complete your treatment.

If you estimate that the effect of this medication is too strong or too weak, inform your doctor or pharmacist.

If you take more Alprazolam than you should

If you have taken more alprazolam than you should, consult your doctor or pharmacist immediately or go to the nearest hospital with this leaflet.

Benzodiazepine overdose generally manifests by different degrees of central nervous system depression, ranging from drowsiness to coma. Symptoms include drowsiness (somnolence), speech disorders (dysarthria), coordination disturbances, confusion, lethargy (prolonged and deep sleep), muscle tone decrease (hypotonia), blood pressure drop, respiratory depression, rarely coma, and very rarely death. Serious sequelae are rare, unless alprazolam is taken with other medications or alcohol.

In case of overdose or accidental ingestion, consult the Toxicology Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

If you forgot to take Alprazolam

Do not take a double dose to compensate for the missed doses.If the missed dose is recent, take your dose immediately, and if not, wait for the next dose without taking a double dose to compensate.

If you interrupt treatment with Alprazolam

Alprazolam treatment can cause dependence, so when discontinuing alprazolam administration abruptly, withdrawal symptoms may appear.

Withdrawal symptoms that may occur include: headache, muscle pain, anxiety, tension, restlessness, confusion, irritability, general feeling of disgust (dysphoria), insomnia, intolerance to light, sounds, and physical contact, paresthesias and cramps in the extremities and abdomen, vomiting, sweating, tremors, depersonalization, hallucinations, and seizures. If this occurs, you should consult your doctor immediately.

If you have any other doubts about the use of this medication, ask your doctor or pharmacist.

Like all medications, Alprazolam Tarbis may have adverse effects, although not everyone may experience them.

Adverse effects that may occur during treatment with alprazolam predominantly occur at the beginning of treatment and generally disappear with continued administration or after a reduction in dose.

Very common adverse effects (may affect more than 1 in 10 people):

• Depression.
• Drowsiness, drowsiness, coordination disorder (ataxia), memory alteration, difficulty articulating words (dysarthria), dizziness, headache.
• Constipation, dry mouth.
• Fatigue, irritability.

Common adverse effects (may affect up to 1 in 10 people):

• Sensation of confusion, disorientation, alteration of sexual desire (libido), anxiety, difficulty sleeping (insomnia), nervousness.
• Abnormal coordination, balance alteration, difficulty concentrating, excessive sleep (hypersomnia), deep and prolonged somnolence (lethargy), tremor.
• Nausea, decreased appetite.
• Blurred vision.
• Dermatitis.
• Sexual dysfunction.
• Weight changes.

Rare adverse effects (may affect up to 1 in 100 people):

• Mental and behavioral disorders (mania), hallucinations, anger reactions, agitation, dependence.
• Memory loss (amnesia).
• Loss of muscle strength.
• Inability to retain urine in the bladder (urinary incontinence).
• Irregular menstruation.
• Abstinence symptoms.

Unknown frequency (cannot be estimated from available data):

• Increased levels of prolactin in the blood (hormone responsible for stimulating and maintaining lactation after childbirth).
• Mental and behavioral disorders (hypomania), aggression, hostility, abnormal thinking, psychomotor hyperactivity, drug abuse.
• Autonomic nervous system imbalance, involuntary muscle contractions (dystonia).
• Gastrointestinal disorder, hepatitis, liver function alteration, yellowing of the skin and white of the eyes (jaundice).
• Peripheral edema.
• Angioedema (swelling under the skin's surface).
• Photosensitivity (exaggerated response to light).
• Urinary retention in the bladder.
• Increased intraocular pressure.

With the use of benzodiazepines, the following may occur:

• Drowsiness, lack of reaction to emotional stimuli (emotional numbing), reduced state of alertness, confusion, fatigue, headache, dizziness, muscle weakness, ataxia, or double vision. These phenomena predominantly occur at the beginning of treatment and generally disappear with continued administration. Occasionally, gastrointestinal alterations, changes in sexual desire, or skin reactions may occur.
• A loss of memory (amnesia) may develop, which may be associated with inappropriate behavior.
• The use of benzodiazepines may unmask an existing depression.
• When using benzodiazepines or similar compounds, reactions such as restlessness, agitation, irritability, aggression, delirium, anger attacks, nightmares, hallucinations, psychosis, inappropriate behavior, and other conduct alterations may occur. These reactions can be severe and occur more frequently in children and the elderly.

The administration of the product (even at usual doses) may lead to the development of physical dependence. Discontinuation of treatment may lead to the development of withdrawal or rebound phenomena. It may produce psychological dependence. Cases of abuse have been reported.Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that does not appear in this prospectus. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicinal Products for Human Use: www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

Keep this medication out of the sight and reach of children.

Do not store at a temperature above 25 °C.

Store in the original packaging to protect it from light and humidity.

Do not use this medication after the expiration date that appears on the packaging after "Cad." The expiration date is the last day of the month indicated.

Medications should not be disposed of through drains or in the trash. Dispose of packaging and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medications. By doing so, you will help protect the environment.

Composition of Alprazolam Tarbis 0.25 mg tablets EFG

• The active ingredient is alprazolam. Each tablet contains 0.25 mg of alprazolam.
• The other components (excipients) are: sodium docusate, sodium benzoate (E-211), pregelatinized potato starch, microcrystalline cellulose (E-460), lactose monohydrate, magnesium stearate (E-572), and anhydrous colloidal silica.

Appearance of the product and content of the packaging

It is presented in scored white, oblong tablets, engraved with “APZM 0.25” on one side. Each package (blister) contains 30 tablets.

Other presentations:

Alprazolam Tarbis 0.5 mg tablets EFG, package with 30 tablets.

Alprazolam Tarbis 1 mg tablets EFG, package with 30 tablets.

Alprazolam Tarbis 2 mg tablets EFG, package with 30 and 50 tablets.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization:

Tarbis Farma, S.L.

Gran Vía Carlos III, 94,

08028 Barcelona

Responsible for manufacturing

Dragenopharm Apotheker Püschl GmbH Co. KG

Göllstrasse 1, 84529 Tittmoning

Germany

The last review of this leaflet was inJanuary2023

The detailed information of this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/